Company ยท US
Convatec, A Division of E.R. Squibb & Sons
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 2009. Name variants (Inc, Corp, punctuation) are merged.
84510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FRO | Dressing, Wound, Drug | 16 |
| KMF | Bandage, Liquid | 13 |
| EXB | Collector, Ostomy | 9 |
| KGX | Tape And Bandage, Adhesive | 6 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 5 |
| EYQ | Garment, Protective, For Incontinence | 4 |
| LRJ | Disinfectant, Medical Devices | 4 |
| NAD | Dressing, Wound, Occlusive | 4 |
| EXJ | Device, Incontinence, Urosheath Type, Sterile | 3 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | 3 |
| EXI | Device, Paste-On For Incontinence, Sterile | 2 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 2 |
| KNY | Accessories, Catheter, G-U | 2 |
| MCY | Wound Dressing Kit | 2 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 2 |
| EXD | Irrigator, Ostomy | 1 |
| EXE | Protector, Ostomy | 1 |
| KMK | Device, Intravascular Catheter Securement | 1 |
| KOX | Solvent, Adhesive Tape | 1 |
| KOZ | Beads, Hydrophilic, For Wound Exudate Absorption | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 4, 2009 | K090254 | SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) Convatec, A Division of E.R. Squibb & Sons, LLC | FRO |
| May 2, 2008 | K080383 | AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING Convatec, A Division of E.R. Squibb & Sons, LLC | FRO |
| Apr 16, 2007 | K063271 | AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSING Convatec, A Division of E.R. Squibb & Sons, LLC | FRO |
| Jun 21, 2002 | K013814 | ABSORBENT ANTIMICROBIAL WOUND DRESSING Convatec, A Division of E.R. Squibb & Sons | FRO |
| May 18, 1999 | K990964 | SIGNADRESS DUODERM DRESSING Convatec, A Division of E.R. Squibb & Sons | KGN |
| Mar 3, 1999 | K984388 | HA ABSORBENT WOUND DRESSING Convatec, A Division of E.R. Squibb & Sons | KGN |
| Apr 15, 1998 | K980720 | NONWOVEN PAD Convatec, A Division of E.R. Squibb & Sons | KMF |
| Mar 9, 1998 | K980382 | NON-WOVEN COMPRESS Convatec, A Division of E.R. Squibb & Sons | KMF |
| Feb 20, 1998 | K974823 | NONWOVEN DRESSING Convatec, A Division of E.R. Squibb & Sons | KMF |
| Feb 6, 1998 | K974205 | KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON Convatec, A Division of E.R. Squibb & Sons | KMF |
| Jan 13, 1998 | K974304 | GERMICIDAL CLOTH Convatec, A Division of E.R. Squibb & Sons | LRJ |
| Dec 22, 1997 | K973632 | DUODERM CGF CONTROL GEL FORMULA DRESSING Convatec, A Division of E.R. Squibb & Sons | FRO |
| Oct 1, 1997 | K972530 | CONVATEC ODOR CONTROL WOUND DRESSING Convatec, A Division of E.R. Squibb & Sons | KMF |
| Aug 14, 1997 | K972062 | CONVATEC NON-ADHESIVE DRESSING Convatec, A Division of E.R. Squibb & Sons | KMF |
| Dec 16, 1996 | K964835 | COVERAGE SPRAY HBV Convatec, A Division of E.R. Squibb & Sons | LRJ |
| Dec 13, 1996 | K964749 | COVERAGE HBV Convatec, A Division of E.R. Squibb & Sons | LRJ |
| Oct 25, 1996 | K963265 | PROSYS SAMEC LA Convatec, A Division of E.R. Squibb & Sons | EXJ |
| Oct 7, 1996 | K962739 | T.B.Q. Convatec, A Division of E.R. Squibb & Sons | LRJ |
| Sep 20, 1996 | K962590 | SIGNALDRESS Convatec, A Division of E.R. Squibb & Sons | FRO |
| Jul 18, 1996 | K962604 | PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING Convatec, A Division of E.R. Squibb & Sons | FAQ |
| Jul 8, 1996 | K961319 | EPIVIEW Convatec, A Division of E.R. Squibb & Sons | MGP |
| Dec 20, 1995 | K953767 | PROSYS BEDSIDE DRAINAGE BAG Convatec, A Division of E.R. Squibb & Sons | FAQ |
| Aug 15, 1995 | K952208 | PROSYS LEG BAG Convatec, A Division of E.R. Squibb & Sons | KNX |
| Jun 12, 1995 | K951022 | CIRCULON SYSTEM STEP 1 Convatec, A Division of E.R. Squibb & Sons | MCY |
| Jun 12, 1995 | K951021 | CIRCULON SYSTEM STEP 2 Convatec, A Division of E.R. Squibb & Sons | MCY |
| May 25, 1995 | K951945 | PROSYS LEG BAG Convatec, A Division of E.R. Squibb & Sons | FAQ |
| May 12, 1995 | K951530 | PROSYS URIHESIVE SYSTEM LA Convatec, A Division of E.R. Squibb & Sons | EXJ |
| Mar 23, 1995 | K950690 | PROSYS URIHESICE SYSTEM NL Convatec, A Division of E.R. Squibb & Sons | EXJ |
| Aug 4, 1994 | K943258 | HYDROCOLLOID WOUND DRESSING Convatec, A Division of E.R. Squibb & Sons | KMF |
| Mar 1, 1994 | K935948 | CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM Convatec, A Division of E.R. Squibb & Sons | KGX |
| Jan 12, 1994 | K925004 | ALLKARE BARRIER WIPE Convatec, A Division of E.R. Squibb & Sons | KMF |
| Dec 27, 1993 | K932101 | DUODERM IMPROVED CGF CONTROL GEL FORMULA DRESSING Convatec, A Division of E.R. Squibb & Sons | MGQ |
| Dec 23, 1993 | K926230 | EPIDRESS & DERMASORB HYDROCOLLOID ALGINATE DRESSIN Convatec, A Division of E.R. Squibb & Sons | KMF |
| Dec 10, 1993 | K931618 | DUODERM HYDROCOLLOID GEL Convatec, A Division of E.R. Squibb & Sons | NAE |
| Dec 1, 1993 | K932143 | FLEXI-TRAK ANCHORING DEVICE Convatec, A Division of E.R. Squibb & Sons | KNY |
| Oct 28, 1993 | K925993 | DUODERM HYDROACTIVE DRESSING Convatec, A Division of E.R. Squibb & Sons | KMF |
| Oct 28, 1993 | K925991 | DUODERM CGF CONTROL GEL FORMULA DRESSING & BORDER Convatec, A Division of E.R. Squibb & Sons | KMF |
| Oct 28, 1993 | K925990 | DUODERM EXTRA THIN CGF DRESSING Convatec, A Division of E.R. Squibb & Sons | KMF |
| Oct 15, 1993 | K925992 | DUODERM TRANSPARENT HYDROCOLLOID DRESSING Convatec, A Division of E.R. Squibb & Sons | KMK |
| Jun 22, 1993 | K924755 | CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION Convatec, A Division of E.R. Squibb & Sons | EXI |
| Apr 20, 1993 | K924976 | ALLKARE(TM) ADHESIVE REMOVER WIPE Convatec, A Division of E.R. Squibb & Sons | KOX |
| Aug 18, 1992 | K920675 | DUODERM SUSTAINED COMPRESSION BANDAGE Convatec, A Division of E.R. Squibb & Sons | KGX |
| Jan 23, 1992 | K915616 | URIHESIVE STRIP Convatec, A Division of E.R. Squibb & Sons | EXI |
| Sep 4, 1991 | K912667 | DUODERM HYDROACTIVE DRESSING AND CGF DRESSINGS Convatec, A Division of E.R. Squibb & Sons | MGQ |
| Sep 4, 1991 | K912518 | CIRCULON(TM) ADHESIVE COMPRESSION BANDAGE Convatec, A Division of E.R. Squibb & Sons | KGX |
| Aug 14, 1991 | K912550 | DUODERM(R) ADHESIVE COMPRESSION BANDAGE, MODIFIED Convatec, A Division of E.R. Squibb & Sons | KGX |
| Mar 6, 1991 | K904233 | CONVATEC ABSORBENT BANDAGE Convatec, A Division of E.R. Squibb & Sons | EXE |
| Jan 25, 1991 | K904852 | DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK Convatec, A Division of E.R. Squibb & Sons | FRO |
| Nov 29, 1990 | K905128 | FLEXI-TRAK(TM) ANCHORING DEVICE Convatec, A Division of E.R. Squibb & Sons | KNY |
| Nov 21, 1990 | K903645 | DERMASORB WOUND CONTACT LAYER DRESSING Convatec, A Division of E.R. Squibb & Sons | KOZ |
Newest 50 of 84.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||